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【アステラス製薬株式会社】Clinical Trial Manager

年収：900万～ 1100万

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部署・役職名	【アステラス製薬株式会社】Clinical Trial Manager
職種	臨床開発
業種	医薬品メーカー
勤務地	東京都
仕事内容	当社は日本発のグローバル製薬メーカーとして、日本を中心に米州・欧州・アジア・オセアニアに拠点を構え、先端・信頼の医薬で、「世界の人々の健康に貢献する」という経営理念の下、イノベーションを継続的に創出し、患者さんのニーズに応える革新的な医療ソリューションを届けていくという一貫した姿勢で歩んでおります。変化する医療の最先端に立ち、科学の進歩を患者さんの価値に変えていくことで、ステークホルダーや社会からの期待に応え続けます。【募集の背景 / Purpose & Scope】 • This position is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). • This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables. • Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables. 【職務の内容 / Essential Job Responsibilities】（雇入れ直後） • Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. • Leads or supports cross-functional trial teams, including vendors. • Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders. • Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues. • Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data. • Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team. • Participate in or lead feasibility assessment and selection of countries and sites for trial conduct. • Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables. • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans. • Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members. • Provide oversight and direction to trial team members for trial deliverables. • Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems. • Ensure quality and completeness of TMF for assigned clinical trials. • Participates in inspection readiness activities including coordination of clinical trial team deliverables. • Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable. • Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities. （変更の範囲）会社内での全ての業務
労働条件	【勤務開始日 / Start Date】応相談 Will be decided according to the candidate's flexibility 【契約期間 / Contract Duration】期間の定めなし Not limited to specified period 【試用期間 / Probation Period】試用期間原則なし No probation period in principle 【給与 / Salary】 ①基本給：当人の経歴・技術・技能等を考慮して決定 ②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給 ③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給 ①Base salary: will be decided by the candidate's experience, skill and capability. ②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade) ③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours. 【昇給 / Salary Raise】有り【賞与 / Bonus】有り【諸手当 / Allowance】裁量労働手当、住宅手当、通勤手当　等 Discretionary work allowance, Housing allowance, Commutation allowance, etc. 【勤務時間 / Working Hours】 8:45～17:45（月～木）、8:45～16:00（金）、裁量労働制裁量労働制の場合、所定労働時間を働いたものとみなす 8:45～17:45（Mon～Thu）、8:45～16:00（Fri） Discretionary Work System 【休日 / Holidays】完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始 Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays 【休暇 / Vacation Leave】年次有給休暇、育児休業制度、介護休業制度　等 Annual paid leave, childcare leave system, nursing care leave system, etc. 【福利厚生 / Welfare】雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度　等 Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
応募資格	【必須（MUST）】 • BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience. • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements. • Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring. • Requires project management skills and trial leadership ability. • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. • Fluent in English. • Moderate (~25%) travel required. 【歓迎（WANT）】 • Advanced Degree 【就業環境に関する要件 / Specific Physical or Environmental Requirements】 At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
アピールポイント	自社サービス・製品あり日系グローバル企業女性管理職実績あり上場企業従業員数1000人以上シェアトップクラス創立30年以上年間休日120日以上産休・育休取得実績あり教育・研修制度充実完全土日休み
受動喫煙対策	屋内禁煙
更新日	2025/07/30
求人番号	5254701

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アステラス製薬株式会社

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